FDA 510(k) Ophthalmic Devices
FDA 510(k) Ophthalmic Devices - Regulatory Overview
FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.
Main categories:
- Contact lenses - daily, extended wear, toric and multifocal lenses
- Intraocular lenses (IOLs) - monofocal, toric and premium IOLs for cataract surgery
- Ophthalmic lasers - excimer lasers for LASIK, Nd:YAG, photocoagulation
- Retinal imaging systems - OCT, fundus cameras, fluorescein angiography
- Diagnostic instruments - tonometers, perimeters, autorefractors, slit lamps
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2893 Ophthalmic devices
Cleared
Jun 09, 1997
BAYERS BIMANUAL I/A HANDPIECES
HQC
Unit, Phacofragmentation
77d
Cleared
Jun 05, 1997
GLARE WARE
HQY
Sunglasses (non-prescription Including Photosensitive)
91d
Cleared
Jun 04, 1997
DUQIAO
HQY
Sunglasses (non-prescription Including Photosensitive)
37d
Cleared
May 29, 1997
PATHFINDER SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
35d
Cleared
May 28, 1997
KASHA VISUAL FIELD SYSTEM
HPT
Perimeter, Automatic, Ac-powered
61d
Cleared
May 22, 1997
ML DISPOSABLE ALK TUBING
KYG
Device, Irrigation, Ocular Surgery
52d
Cleared
May 21, 1997
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
LPL
Lenses, Soft Contact, Daily Wear
61d
Cleared
May 21, 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
51d
Cleared
May 20, 1997
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
MMQ
Topographer, Corneal, Ac-powered
176d
Cleared
May 20, 1997
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
HMX
Cannula, Ophthalmic
71d
Cleared
May 20, 1997
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
MPA
Endoilluminator
71d
Cleared
May 20, 1997
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK)
LPL
Lenses, Soft Contact, Daily Wear
25d
Cleared
May 14, 1997
D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
147d
Cleared
May 13, 1997
MBI ILLUMINATED RETINAL PICK
MPA
Endoilluminator
190d
Cleared
May 13, 1997
MBI CO-AXIAL ILLUMINATED RETINAL PICK
MPA
Endoilluminator
181d
Cleared
May 13, 1997
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
HQY
Sunglasses (non-prescription Including Photosensitive)
77d
Cleared
May 13, 1997
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
27d
Cleared
May 09, 1997
TOMEY DTL ELECTRODE
HLZ
Electrode, Corneal
364d
Cleared
May 09, 1997
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
70d
Cleared
May 09, 1997
UNIKA
HQY
Sunglasses (non-prescription Including Photosensitive)
29d
Cleared
May 06, 1997
EVEREST SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
99d
Cleared
May 06, 1997
LAXIMA INTERNATIONAL LIMITED SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
90d
Cleared
May 06, 1997
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)
HQY
Sunglasses (non-prescription Including Photosensitive)
88d
Cleared
May 06, 1997
REUSABLE VITRECTOMY PROBE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
71d
Cleared
May 06, 1997
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
70d
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